Z-0458-2022Class II

UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile

Name: Z-0458-2022 UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile
Creator: Uromedica Inc.
Published: 2021-11-22
License: https://open.fda.gov/license/

Uromedica Inc. / initiated 2021-11-22 / Terminated / root cause: manufacturing process

FDA source

Uromedica Inc. began a recall of UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile on 2021-11-22. FDA classified it as Class II and gives the reason as "The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0458-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-22
Posted: 2022-01-05
Terminated: 2023-08-11
Recalling firm: Uromedica Inc.
Product: UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Product code: EZY Device, Incontinence, Mechanical/Hydraulic
Reason for recall: The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Letters dated 11/22/2021 were issued via email to the consignees explaining the reason for recall. The consignee is requested to identify and remove the affected u-channel sheath and sharp trocar from circulation at their facility. The consignee will be contacted by a Uromedica representative who will schedule an in-person visit and collect the affected U-channel sheath and sharp trocar. Once the instruments have been removed from the facility, replacement instruments will be provided.
Quantity in commerce: 18 devices
Distribution: US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
Product codes and lots: Lot numbers UM00794 and UM00817, UDI 00180668000106

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0458-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0458-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-12	2022-01-05

Product code EZY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)